Based in Cambridge, Massachusetts, biotechnology small cap Genocea Biosciences (NASDAQ:GNCA) provided a second quarter 2020 business update before the market open on July 23rd. The update included information about its current product candidates as well some financial figures from the recent quarter.
The favorable report helped propel shares of Genocea higher for the sixth straight day. The stock is approaching its 52-week high of $3.83 after closing at $3.60 on the day of the report.
The company presented long-term follow up data on GEN-009 from Part A of its ongoing phase 1/2a clinical trial at the ASCO20 Virtual Scientific Program. GEN-009, Genocea’s lead program, is a personalized cancer vaccine that is being developed for the treatment of patients with solid tumors.
The GEN-009 study evaluated eight patients for duration of immune responses and clinical outcomes. Seven of the patients were reported to be without disease progression at the median follow-up period of one year. Moreover, neoantigens identified by Genocea’s ATLAS platform generated broad, sustained T cell responses after only four weeks that lasted for as much as one year following the last vaccination. The company’s proprietary ATLAS technology profiles an individual’s T cell responses to potential targets on a tumor known as antigens.
Genocea also filed an investigational new drug (IND) application for a phase 1/2a clinical study of its latest therapy GEN-011 which uses peripheral blood T cells to target the right tumor neoantigens. It expects to enroll as many as 24 patients and assess multiple tumor types. The U.S. Food and Drug Administration (FDA) verbally notified the company that the IND review has been completed and the IND placed on clinical hold pending its receipt of additional information about certain third-party reagents used to manufacture GEN-011.
Private placement expected to improve capital strength
Management also provided second quarter 2020 financial results. It recorded a wider net loss of $11.3 million after posting a $6.5 million loss in the same period a year ago. This was driven by an increase in research and development (R&D) expenses to $8.6 million and an increase in general and administrative (G&A) expenses to $3.5 million.
On July 22nd, Genocea entered into a private placement with several leading life science investment funds to purchase up to $80 million of its common stock in addition to warrants to purchase Genocea stock. The placement will involve the offering of 21.4 million common shares and 12.2 million warrants with a four-year term at an exercise price of $2.25.
The company noted that including the proceeds from the private placement its cash balance will be sufficient to support its operations through the middle of 2022. As of June 30th, 2020, it had a cash and cash equivalents balance of $22.1 million. Depending on the success of the placement, its liquidity position may swell to over $100 million. The private placement is expected to close on July 24th.
Genocea also announced that it plans to present initial clinical data on GEN-009 on July 30th at 8:00am EST. The data will be based on the Part B study of an initial five patients in conjunction with Dr. Maura L. Gillison at MD Anderson Cancer Center. The study is designed to evaluate the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors.
The company is anticipating preliminary clinical results from the phase 1/2a trial of GEN-009 in the third quarter of 2020. It also expects to receive written communication from the FDA regarding the hold of the GEN-011.